Efficacy of an Advanced Care Planning Program in Advanced Heart FAilure (EACPAHFA)

Evaluating the Efficacy of an Advanced Care Planning Program for Health Decisions in Patients With Advanced Heart Failure

An "Advanced Planning Program of Health Decisions" (APPHD) is a process of reflection and relationship between the patient, their relatives and health professionals. It is based on respect for patient's autonomy, to engage patients in making decisions about their disease so that the process is shared between the medical team, the patient and their relatives. Until now, it has not been measured whether the APPHD is effective and, therefore, really fulfills its purpose

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Advanced Care Planning program of health decisions

Detailed Description

BACKGROUND: An Advanced Care Planning (ACP) program of health decisions is the result of a process of reflection and relationship-building between the patient, their relatives and health professionals. It is based on respect for patients' autonomy, involving them in making decisions about their disease in a way that is shared between the medical team, the patient and their relatives. Up until now, the efficacy of an ACP has not been measured in the existing literature, and therefore it is unknown if these programs reach their goal. OBJETIVES: The main objective of our study is to evaluate the efficacy of an ACP program for decision-making in patients with advanced heart failure (HF) in comparison to usual follow up and care. This objective will be evaluated by the Patient Activation Measure test, which measures the participation and self-management of the patient in decision-making. Secondary objectives: to evaluate the effect of the program on quality of life, to know if the patients wishes expressed through the ACP program are fulfilled, to measure the impact of the program on patients' caregivers, to determine the satisfaction of patients included in the program and to evaluate the effect on quality of death. METHODS: randomized multicentre clinical trial at four hospitals in Madrid. Once they are included in the study, patients' allocation to groups (control vs intervention) will be made by alternative sampling. ACP will be applied to the intervention group, whereas in the Control Group usual follow-up will be carried out in HF units. All patients will fulfil questionnaires and tests related to the objectives of the study again after a 12-month follow-up period in order to gauge the effect of ACP in patients with advanced HF.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Recruiting
      • Hospital Universitario Fundacion Alcorcon
      • Contact: Maria Velasco, Head of investigation unit; Phone Number: 916219597; Email: unidadinvestigacion@fhalcorcon.es
      • Contact: Benjamin Herreros, Principal investigator; Phone Number: 630906473; Email: bherreros@fhalcorcon.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with HF defined by Framingham diagnostic criteria.
• Stage C or D of the ACCF / AHA classification.
• Full capacity to decide.
• Signing of informed consent.

Exclusion Criteria:

• Cognitive impairment, measured by Mini-Mental Status Examination (< 27).
• Presence of another disease other than HF that may severely affect the quality of life: stroke with significant residual deficit, end-stage renal failure, Child C cirrhosis, extreme obesity, haemoglobin <8 g / dl, advanced peripheral artery disease (stage III-IV), severe thyroid or adrenal disease, neoplastic with estimated survival of less than 2 years.
• Patients who do not sign the informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients will be followed in heart failure outpatients units according to the usual established protocol. In the first visit, patients from both control and intervention groups will complete the questionnaires with the help of researchers. After one year of follow-up, the questionnaires will be submitted again to all patients and three new questionnaires will be proposed. Treatment for heart failure will be the same in both groups.
Experimental: Intervention; Patients will participate in the Advanced Care Planning Program. In the first visit, patients from both control and intervention groups will complete the questionnaires with the help of researchers. After one year of follow-up, the questionnaires will be submitted again to all patients and three new questionnaires will be proposed. Treatment for heart failure will be the same in both groups.	Behavioral: Advanced Care Planning program of health decisions; Application of an Advanced Care Planning program program for decision-making in patients with advanced Heart Failure, in comparison to usual follow up and care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy of an Advanced Care Planning program for decision-making in patients with advanced Heart Failure in comparison to usual follow up and care: questionnaire	This objective will be evaluated by the PAM (Patient Activation Measure) test, which measures the participation and self-management of the patient in decision making. PAM measures the activation (participation and self-management) of the patient in decision-making. It evaluates the knowledge, skills and confidence of patients' self-management classifying patients in levels of self-management activation. Level 1: They do not feel responsible for their own health and care. (Score 47.0 or lower); Level 2: They may lack basic understanding about their condition, treatment options, and / or self-care. (47.1 to 55.1); Level 3: They know the basic facts of their illness and treatments. (55.2 to 67); Level 4: They have made most of the decisions, but they may have difficulties in maintaining behaviours over time or in stressful situations (67.1 or higher).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effect of the ACP program on quality of life: questionnaire	This objective will be evaluated by the LWHFQ Questionnaire (Minnesota Living with Heart Failure Questionnaire), which measures the quality of life in patients with HF. Scoring range: 0 to 105 points: The higher the score obtained, the poorer the quality of life of patients. Questions refer to signs and symptoms of the disease, social relationships, physical, sexual activity, work and emotions. It is self-administered, with Likert response options, ranging from 0 (quality of life not affected) to 5 (maximum impact on quality of life). The global score is obtained by adding the 21 items scores (range: 0-105); the highest value corresponds to the worst quality of life. It assesses the impact of chronic heart failure in two dimensions: the physical dimension based on eight items (range: 0-40) and the emotional dimension consisting of five items (range: 0-25).	24 months
To know if the patients wishes expressed through the ACP program are fulfilled	This objective will be evaluated by a Checklist to test the fulfilment of planned patient's wishes.	24 months
To determine the level of satisfaction with the ACP program of patients included in the program.	This objective will be evaluated by a Satisfaction test Created "ad hoc". It aims to assess the level of satisfaction with the program. Its outcome will help improve the future implementation of the program. Satisfaction test. Answer YES or NO; Did you understand what the Program was about?; Do you feel you received enough information, orally or in writing, for your understanding?; Did you feel that you could easily access the doctors responsible for the program to answer your questions?; Do you think that the doctors responsible for the program have the necessary skills and knowledge?; Did you understand without difficulty what these professionals communicated in each interview?; Has the program met your expectations and needs?; Did you find it easy to get to the office and / or day hospital?	24 months
To evaluate the effect on quality of death: questionnaire	This objective will be evaluated by the Dying and Death quality questionnaire (QODD). This questionnaire measures the quality of the dying process. Quality of Dying and Death - 17-Item Version: Each item includes a filter question reporting what actually occurred during the final period of the decedent's life, followed by a rating of what occurred. The first 10 filter questions ask the frequency of occurrence and use the following response options: 0: none of the time; 1: a little bit of the time ; 2: some of the time; 3: a good bit of the time; 4: most of the time; 5: all of the time. The last 7 filter questions ask whether the event occurred and are answered with a yes/no response. After each filter question, the respondent rates the decedent's experience, using the following scale: 0 = terrible experience…10 = almost perfect experience.	24 months
To measure the impact of the ACP program on patients' caregivers	This objective will be evaluated by the Zarit questionnaire about caregiver's burden. Zarit questionnaire about caregiver's burden. This interview measures caregivers' degree of subjective overload in relation to chronic patients. It consists of 22 items that collect caregivers' feelings. Each feeling scores on a frequency gradient that ranges from 1 (never) to 5 (almost always). Interpretation: or <45 points: no overload; 47 to 55 points: slight overload; or> 55 points: intense overload	24 months

Collaborators and Investigators

• Sponsor: Hospital Universitario Fundación Alcorcón

Publications and helpful links

General Publications

• Perez M, Herreros B, Martin MD, Molina J, Kanouzi J, Velasco M. Do Spanish Hospital Professionals Educate Their Patients About Advance Directives? : A Descriptive Study in a University Hospital in Madrid, Spain. J Bioeth Inq. 2016 Jun;13(2):295-303. doi: 10.1007/s11673-016-9703-7. Epub 2016 Jan 21.
• Perez M, Herreros B, Martin MD, Molina J, Guijarro C, Velasco M. [Changes in knowledge and carrying out the advance directives of patients admitted to internal medicine]. Rev Calid Asist. 2013 Sep-Oct;28(5):307-12. doi: 10.1016/j.cali.2013.03.008. Epub 2013 Sep 7. Spanish.
• Molina J, Perez M, Herreros B, Martin MD, Velasco M. [Knowledge and attitude regarding previous instructions for the patients of a public hospital of Madrid]. Rev Clin Esp. 2011 Oct;211(9):450-4. doi: 10.1016/j.rce.2011.06.007. Epub 2011 Aug 2. Spanish.
• Miles SH, Koepp R, Weber EP. Advance end-of-life treatment planning. A research review. Arch Intern Med. 1996 May 27;156(10):1062-8.
• Gomez-Batiste X, Martinez-Munoz M, Blay C, Amblas J, Vila L, Costa X, Espaulella J, Villanueva A, Oller R, Martori JC, Constante C. Utility of the NECPAL CCOMS-ICO(c) tool and the Surprise Question as screening tools for early palliative care and to predict mortality in patients with advanced chronic conditions: A cohort study. Palliat Med. 2017 Sep;31(8):754-763. doi: 10.1177/0269216316676647. Epub 2016 Nov 4.
• Sanchez B, Guijarro C, Velasco M, Vicente MJ, Galan M, Herreros B. Evaluating the efficacy of an Advanced Care Planning Program for Health Decisions in patients with advanced heart failure: protocol for a Randomized Clinical Trial. BMC Cardiovasc Disord. 2020 Oct 21;20(1):456. doi: 10.1186/s12872-020-01738-0.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HUFAlcoron

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The databases to be managed will be anonymous
• IPD Sharing Time Frame: 12 months
• IPD Sharing Access Criteria: Study investigators
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No